Practical perspectives on medical device regulation
Insights to navigate regulation, bring medical technologies to market, and improve patient care.
EU Authorised Representative
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.
Review your Technical Documentation like a Notified Body (or UK Approved Body)
A practical walkthrough of what Notified Bodies actually look for when reviewing medical device technical documentation, covering everything from intended purpose and regulatory classification through to risk management and pre-submission checks.
Commonly Misunderstood QMS Definitions: Correction, Corrective Action and Preventive Action
Three QMS terms that get mixed up more often than they should - this post cuts through the confusion to explain the clear difference between fixing a problem that's happened, preventing it from happening again, and stopping it from happening in the first place.
A Guide to Root Cause Analysis
A step-by-step guide to root cause analysis for medical device manufacturers, walking through everything from writing a clear problem statement and containing the issue, to implementing corrective action and checking it's actually worked.
Quality Policy Statement Example
A no-fuss, ready-to-use quality policy statement template that covers the core ISO 9001 requirements without overcomplicating things - just fill in your company name and go.
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